A collaboration project, ‘Improving Downstream Operation through Formulation Innovation’, from Arecor and FUJIFILM Diosynth Biotechnologies, has successfully completed its initial rounds of performance testing and is on track for completion in November
Measure success
The aim of the collaborative project is to achieve a step change in biopharmaceutical yield and quality by improving product stability during downstream processing (DSP). To achieve this, the partners are developing a novel formulation platform that can be applied to routine biopharmaceutical manufacturing to deliver improvements in the performance of DSP, while also reducing manufacturing costs.
DSP is a critical step for removing impurities and contaminants during the manufacture of biopharmaceutical proteins, however, it can also be the cause of product destabilisation and has been reported to account for approximately 60% of cost in biopharma manufacturing. Therefore, novel technology and development approaches would benefit yield and overall protein stability.
To develop the novel formulation platform for improving DSP, smart formulations were identified by the collaboration so that product stability can be improved in areas of DSP where the protein is more sensitive to degradation. Using Arecor’s innovative and proprietary technology platform, Arestat, and the industrial bioprocessing experience and expertise of FDB and CPI, novel Arecor protein stabilisation formulations for DSP applications were developed and tested.
“Improved efficiency and quality is a clear goal for downstream processing operations as they struggle to support recent advances in formulations which have led to large improvements in upstream yields. This encouraging early data is the first step in demonstrating how, through Arecor’s unique stabilisation technology and CPI’s and FUJIFILM Diosynth Biotechnologies DSP expertise, a novel downstream processing formulation platform developed during the project has the potential to deliver lower cost biopharmaceuticals with improved quality profiles,” said David Gerring, head of development, Arecor.
“CPI is delighted to be working with Arecor and FUJIFILM Diosynth Biotechnologies on this project, which has been showing very positive results,” added Dr John Liddell, senior scientific advisor, Centre for Process Innovation. “This promising work brings us a step closer to achieving the collaboration’s goal of developing a novel downstream processing formulation platform that can be applied to routine biopharmaceutical manufacturing, to deliver significant improvements in the performance of downstream process operations with reduction in manufacturing costs,”
“FDB is delighted to be collaborating with Arecor and CPI on new downstream processing platforms as part of our on-going technology development activity and our commitment to lead the global Biologics CDMO industry through the continuous innovation of technologies, service delivery and quality for the benefit of our customers and their patients,” asserted Dr Andy Topping, chief scientific officer, FUJIFILM Diosynth Biotechnologies.
The project is supported by grant funding from Innovate UK under its £20 million Industrial Biotechnology Catalyst (IBC) scheme.